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NCT02546531 · ClinicalTrials.gov registry record · Phase 1
Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02546531: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT02546531 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02546531, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in the preclinical setting. Furthermore, a maximal synergetic effect was achieved when a FAK inhibitor was given in combination with a PD-1 antagonist and chemotherapy in multiple pancreas tumor animal models. This supports the concept of using FAK inhibitors to reduce stromal fibrosis during checkpoint immunotherapeutic treatment. Therefore, these robust preclinical findings will be tested in the proposed phase I trial.
Primary Outcome
* The recommended phase II dose will be determined from the maximum tolerated dose (MTD) found in the dose escalation cohort. * The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle (21 days). Dose escalations will proceed until the MTD has been reached or the completion of cycle 5.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Gemcitabine
- BIOLOGICAL Defactinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-02-03 |
| Est. Completion | 2021-01-11 |
| Phase | Phase 1 |
What the finished NCT02546531 record still lists
NCT02546531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02546531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02546531 about?
NCT02546531 is a clinical study titled "Defactinib Combined With Pembrolizumab and Gemcitabine in Patients With Advanced Cancer". In pancreatic cancer, targeting the tumor microenvironment has become a promising therapeutic strategy. Focal adhesion kinase (FAK) pathway activation is essential for promoting a fibrotic and inflammatory tumor microenvironment, and FAK inhibitors have demonstrated reasonable anti-tumor activity in...
What is the current status of trial NCT02546531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2016-02-03. Estimated completion is 2021-01-11.
What interventions are being tested in trial NCT02546531?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Gemcitabine (DRUG), Defactinib (BIOLOGICAL).
Who is sponsoring clinical trial NCT02546531?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02546531's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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